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Guidance on Clause 4.2 - Documentation Requirements
a) Quality Policy and Objectives:
* Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2000. Because the quality policy is a document, it must be controlled according to the requirements of clause 4.2.3. Some companies that may be revising their quality policy for the first time, in order to meet ISO 9001:2000 requirements will need to pay particular attention to clause 4.2.3 (c), (d) and (g).
* Requirements for the quality objectives are defined in clause 5.4.1 of ISO 9001:2000. They are also subject to the document control requirements of clause 4.2.3.
b) Quality Manual:
* Clause 4.2.2 of ISO 9001:2000 specifies the minimum content for a quality manual. The format of the manual is a decision for each company, and will depend on the company’s size, culture and complexity.
* A small company may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
* Large, multi-national companies may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
c) Documented procedures:
* ISO 9001:2000 specifically requires the company to have "documented procedures" for the following six activities:
4.2.3 Control of documents
4.2.4 Control of quality records
8.2.2 Internal audit
8.3 Control of nonconformity
8.5.2 Corrective action
8.5.3 Preventive action
* Some companies (particularly larger companies, or those with more complex processes) may require additional documented procedures in order to implement an effective QMS.
* Other companies may require additional procedures, but the size and/or culture of the company could enable these to be effectively implemented without necessarily being documented.
* In order to demonstrate compliance with ISO 9001:2000, however, the company must be able to provide objective evidence that its QMS has been effectively implemented.
d) Documents required by the company
To ensure the effective planning, operation and control of its processes:
In order for a company to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2000 are:
* Quality Policy (clause 4.2.1 a)
* Quality Objectives (clause 4.2.1 a)
* Quality Manual (clause 4.2.1 b)
* There are several requirements of ISO 9001:2000 where an company could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:
* Process Maps
* Company Charts
* Internal Communications
* Production Schedules
* Approved Supplier Lists
* Quality Plans
e) Quality Records
* Examples of quality records specifically required by ISO 9001:2000 are listed in the list ‘Records Required’ herein.
* Companies are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
* Requirements for the control of records are different from those for other documents, and all quality records must be controlled according to clause 4.2.4.
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